
BackgroundStepped‐wedge cluster randomized trial (SW‐CRT) designs are often used when there is a desire to provide an intervention to all enrolled clusters, because of a belief that it will be effective. However, given there should be equipoise at trial commencement, there has been discussion around whether a pre‐trial decision to provide the intervention to all clusters is appropriate. In pharmaceutical drug development, a solution to a similar desire to provide more patients with an effective treatment is to use a response adaptive (RA) design.MethodsWe introduce a way in which RA design could be incorporated in an SW‐CRT, permitting modification of the intervention allocation during the trial. The proposed framework explicitly permits a balance to be sought between power and patient benefit considerations. A simulation study evaluates the methodology.ResultsIn one scenario, for one particular RA design, the proportion of cluster‐periods spent in the intervention condition was observed to increase from 32.2% to 67.9% as the intervention effect was increased. A cost of this was a 6.2% power drop compared to a design that maximized power by fixing the proportion of time in the intervention condition at 45.0%, regardless of the intervention effect.ConclusionsAn RA approach may be most applicable to settings for which the intervention has substantial individual or societal benefit considerations, potentially in combination with notable safety concerns. In such a setting, the proposed methodology may routinely provide the desired adaptability of the roll‐out speed, with only a small cost to the study's power.
sequential allocation, clinical trial, interim analysis, Applications of statistics to biology and medical sciences; meta analysis, multi-stage, Treatment Outcome, Research Design, adaptive design, Cluster Analysis, Humans, Computer Simulation, Research Articles, Randomized Controlled Trials as Topic
sequential allocation, clinical trial, interim analysis, Applications of statistics to biology and medical sciences; meta analysis, multi-stage, Treatment Outcome, Research Design, adaptive design, Cluster Analysis, Humans, Computer Simulation, Research Articles, Randomized Controlled Trials as Topic
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 1 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Average | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Average | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Average |
